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Maybe a group had dizziness, with or without a fall, and ended up in the hospital which would then be a serious AE. Administration in the evening or slower titration would then also limit the SAE's. But that's the best imaginable explanation. We just don't know after 2 years of hiding it. Sabbagh added the SAEs in his presentation without more details. Was that a compromise between him and Missling, the co-author? He should refrain from co-authorships as well. Just leave it to more credible medical people.
Dr Missling has at least not been very forthcoming about the safety details. He should refrain from giving medical-scientific presentations and also not be co-author at publications. It's just not credible as a CEO and he is too much inclined to paint the results favourably. This is a clear example about it.
Missling always stated that here were no serious AEs, but Prof. Sabbagh's presentation (slide 22) at AAIC shows SAEs 10% on placebo, 15% on 30 mg and 18.4% on 50 mg. Relatedness not mentioned. There are strict criteria for defining seriousness, whereas assessment of relatedness can be influenced by the sponsor or CRO. This shows a clear increase of SAE's on blarcamesine. Maybe the company says they were all not related to therapy, but why is there such an increase then? Probably it's still much better than on the MABs, but the details should have been given and it will certainly not be ignored by the EMA or FDA.
Just look at the data and be a little bit critical. All BS about fudsters is like putting your head in the sand. The company should have provided more info about these patients. Just saying they are not related doesn't make sense if there is a clear increase in serious AE's. How else could this be explained?
Participants with ≥1 serious TEAEs, 30 mg: 25 (15·0%), 50 mg 31 (18·4%), placebo 17 (10·1%);
There is a clear increase in serious AE's. That's the data we have.
From prof Sabbagh's presentation at AAIC 2024, slide 22:
Adverse Events Summary:
Participants with ≥1 serious TEAEs, 30 mg: 25 (15·0%), 50 mg 31 (18·4%), placebo 17 (10·1%)
So, a clear increase in SAEs on blarcamesine, higher on 50 mg, but no further details provided. They may say that the SAE's were considered not to be related, but with the increase that is not very believable.
They lack experienced people in launching products, with ten management team members but no serious medical/marketing backgrounds. I also checked Linkedin for that. They rather make fancy slides and put them on a hidden site and call it ‘disruptive’ or prepare a study in another brilliant indication. Look at their corporate presentation slide 27: ‘Exploring Commercial Activities’. It’s just a woke joke. In Europe it’s even worse, KOL’s can influence the future decision of EMA and reimbursement, but they are not being educated. Ego-building for Dr. Missling, but no preparation of the market.
This activity is supported by an independent educational grant from Anavex Life Sciences Corp.
I know too well how such independent educational grants work...
Another claim again, ‘complimentary to the Mabs’ without any clinical data to support it. A theoretical idea that probably came up after a German beer, in addition to ‘precision medicine’. They probably didn’t think it through and never tested the concept. Such claims without supporting evidence are unfounded, not necessary, distracting and will lead to discussions that make regulators and KOLs suspicious of all other claims. There is no need to be afraid for big pharma, they should be concerned about the scarcity of their clinical data and not make additional claims that would even need more proof. Missling plays the genius again, but should focus on delivering the basic work.
The slide at 14.54 'Exploring commercial activities' is full of BS. I think he got that slide from an cheap agency that tried to sell him something and he just copied it into his own deck, without understanding what's on it. It's just one slide, but it summarizes the current status of commercial plans. Apparently, there is also nobody that gives him critical feedback, or he doesnt't listen to it.
I don’t understand why the filing takes so long, as normally it’s done within about 9-12 months from database lock. Before the studies read out most analyses can be prepared, computer programs made and text can be created. Depending on the results some extra analyses, additions and changes will be needed. However, in this case it’s only one study, with well-defined efficacy parameters, straightforward analyses, no safety issues, very limited competition and high unmet need. So, how difficult can it be?
If they are waiting for open extension data, or a peer-reviewed paper then it’s foolish, as such data has very limited value and can always be added later in the process. There is a big risk that they just waste a valuable year before hearing the unavoidable answer. They should get the feedback from regulators ASAP and base next steps on that.
For eligibility assessment the sponsor doesn't see all data, just a summary and quickly assesses if all data needed is potentially available and has a quick look at the results. He provides an advice, the CHMP votes about it and if yes, the company can submit. It's no guaratee the drug will be approved, just thoroughly assessed. Aducanumab was rejected after full submission.
CHMP appoints sponsors to review the eligibility.
This review of eligibility applications will take place over 2 consequent CHMP meetings because of the need to appoint a sponsor(s) to assess the request.
These sponsors are members from the CHMP. Assessment is done in their country in collaboration with staff of EMA. Sponsors often become (co-)rapporteur.
https://www.ema.europa.eu/en/documents/other/chmp-rules-procedure_en.pdf
EMA is the whole organisation.
CHMP is a group representatives from the individual countries, one each.
A rapporteur and co-rapporteur will be selected to assess the file (from the members of the CHMP).
The rapporteur and co-rap selects experts (in their respective countries) to assess the application. Each country has experts, sort of Billy Dunn's from the FDA.
These experts make an assessment report. That goes to the CHMP and they vote. That CHMP recommendation has to be approved by the EMA. That often takes an additional 3 months.
Thanks frrol, that's very valuable insight.
I can add that it's certainly not a done deal in Europe, for some of the reasons you give. I know the European regulatory situation very well, not specifically for AD. Broad KOL support is important and can really help in difficult situations. Not really needed for a breakthrough medicine with excellent data, but very needed here. If they don't approve it, it could seriously damage the company. If regulators have made up their minds, it's difficult to change, also for stupid ego reasons. Better to act proactively.
Thank you. I understand some members are heavily bought into this and I'm hurting their baby. From my side it's difficult to see the stock going down while for me obvious next steps are not taken.
Yes, I am late at this forum, but I have been at many neurology conferences for other indications), I have been following Anavex for about 2 years, among many other companies and different fora and with >20 years relevant experience. This is indeed how it works, competitors making the story about you and trying to undermine. Biogen and Lilly are strong in it and Anavex is not doing it in a clever way. Just naive and amateuristic, with a very few persons, Missling playing the brilliant mind, with no clue how it really works. Then indeed you may better give up and sell of.
I agree on nearly everything you said and see what Missling has done well, building this company, finances look good and the studies are OK. And that the belief by the general market is very low. But that can be addressed to some extent, and he doesn't make the necessary steps. The company is not present at medical meetings where the competition is all over the place, there are no activities, only big words about disruptive ai, brilliant new data etc. His presentations are poor, not focussed on the key issues, messages are vague and not consistent. Then everyone indeed loses trust.
I can imagine why Toutain left, being the only commercial person in the company, without staff or money to spend and simultaneously seeing the company as a sitting duck under fire and the stock constantly declining.
That's an interesting molecule, with a mechanism that follows the Karuna drug. The right POC study has just started. Until more data are available we have no idea if it really works or what dose is needed and when. There are also effective comparators on the market. Finance would probably estimate around 1-5% chance that it will finally come on the market, after many years of study. Nice asset to have though, but far more data is needed. Don't get too excited about it, since most drugs at this stage fail.
So, let’s for now agree on this: Blarcamesine works in AD, has at least some effect, with no safety issues. There is nothing comparable on the market and the drug can be cheaper than competitors. There is a large unmet medical need and the AD market is very big. So, it can easily become a blockbuster. First registration in Europe, maybe already in a year or so.
BP has spent billions and billions to find such a drug, Pfizer alone probably 10B. Market capital of Anavex is 300M. The share price only goes down, even now more and more of the positive data are released.
In my view 300M at this stage is peanuts and nothing comparable with any company with such an asset and put the company at risk for a cheap takeover.
My question: Who is responsible for that dramatic result? What is missing?
If people are punished and beaten over and over for a long time, losing everything, they become angry, suspicious, depressed and think that everyone is conspiring against them. It’s very sad and difficult to treat.
Thanks, that's a good step already. So maybe it's a start of a few more changes.
The scientific advisory board provides high level external input in the design of trials, new science and market insights. However, formally appointed consultants also have their own interests. They get a hefty pay for a few hours of work and will not go against Missling. Their influence in a company can be high, whereas they do not really know how to launch a product or how to further develop a company. Anavex still needs experienced people from the pharma industry for the strategy, to prepare everything and work with a large varying group of KOLs and institutions. A few high-level scientific consultants in an company advisory board is good, but a start only.
Yes, I fully agree. I also looked up the linkedin profiles of the employees. Maybe there is one hidden excellent person without linkedin, but for the rest it's all science, regulatory and 'great disruptive ai'. Probably all followers who will not speak up. He needs to surround him with more people who can design and implement a go-to-market strategy and communicate, or just leave.
The plan is OK, but if a BP company would be interested in spending such amounts, then it's far cheaper and more efficient to just buy the whole company. Now there is no trust in much they say, in the data, or in management, reflected in the low share price. I would first improve communications, reach out to external experts, scientific institutions, congresses and patient organizations, have some high level activities and gain some credibility. Focus only on blarcamesine in AD. The share price will follow and then much better deals can be made. This looks like a big effort but could be done with a few people and limited investment. At this stage all companies with some money do it this way and it works. It will also improve the chances for approval and a favourable SmPC.
Go to their website, e.g. under 'news' the most recent thing is from 2022, as well under the quick link 'presentations'. His presentations are also full of redundancies and lack focus. He just doesn't realize how important the right communication is and nobody will tell him.
Thanks, Im an internist with a long background in global big pharma and biotech, clin dev, medical and management. Also investing in a few areas as far as allowed.
I wouldn't count on it, as many people will like a sudden 100% premium. It would be better to do the right activities now, for only a small amount of money. Then the share price can easily go above 10 and gradually higher. That's a much better defense and everyone here will like it.
The data seem to indicate a real effect, better and safer than the competition. A small effect though, and based on limited data, but probably enough to get it approved and reimbursed if everything is done in the right way. However, the constant delays, mixed messages and lack of initiatives made me concerned, as well as the very limited medical-commercial knowledge in the company. If they want to partner next steps, then that's fine, but they should not wait any longer then. At this moment a big pharma company could buy the whole business for 600M and have a blockbuster in a few years. Then most of us have lost a lot of money.
Yes, a nice story about Ern, and also about the 6 'strong reactions' among 32 pts. If the media were full with stories like those of Ern, that would certainly help, but I only see that 1 patient, again and again. I know patients that were suddenly cured from metastatic cancer after a diet, praying or homeopathy. This is not the middle ages anymore. We have agreements on requirements to prove that a medicine works. In any trial you will find some strong responders afterwards, and may regret you didn't do it only in that subgroup. Next time it may be very different, just by chance.
Let the company prospectively clearly define a subgroup of potential strong responders and do a controlled trial in that group. If there is a large and significant effect Vs placebo. then you may have a transformative precision medicine. Not now.
You seem to know a lot of data, I respect that, but apparently you do not really know how science works.
Yes, I know. It's very limited and seldomly targeting the scientific community. Far from what any serious and succesful company would do at this stage. Maybe you should try to argue with data and insights instead of giving some bitter one-liners.
This arrogance... So, what am I missing here? I know the data very well and have the right background to assess.
After 48 weeks ADAS-Cog13 decreased with about 4.6 Vs 7.3 units on placebo. So, on treatment patients are still suffering and the disease progresses, but somewhat less than on placebo. Results may even seem better than on competitor drugs, but that’s unproven, as this is no H2H trial and patient groups are different. So, probably a small real effect, but via an unproven mechanism, in one small trial, not significant in all parameters, without comparison with drugs already on the market.
It may even be enough to get regulatory approval, the biggest hurdle now, but the delays in filing and peer-reviewed paper already shows that this is not a slam dunk. Very rich Big Pharma will be pushing back, influencing the market with any means they have.
You cannot target regulators, but indirectly you can influence them by building support from the market. It's naive to think it's all about science and data. At the moment scientific organizations and KOL networks are hardly aware of Anavex. Except from a seldom article in an Australian newspaper, there Is nothing and company presentations are very scarce and poorly performed.
People with experience in launching a drug could tell him, but there is nobody.
Probably Jiong Ma is a good asset for the company, but with no experience at all in launching a new drug in the market.
I looked at board members, management and Linkedin profiles. There is really nobody with medical, marketing, market access, or sales experience launching a drug. At this stage they need to build KOL support to get the drug approved and reimbursed in the major countries. That doesn't go by itself and takes time. Anyone who has ever launched a drug knows that. Such colleagues would know how to do premarketing, build a story around a new drug, create effective messages, prepare various activities and build a network of external key opinion leaders (KOLs) supporting the drug and company. That all lacks here. Also regulators and payers sometimes speak with KOLs about new developments and if they don't hear anything positive it will be bad for the company and drug. All big companies nowadays start (very) early on with some marketing, medical and market access persons. Now there is nobody which explains the amateuristic communications, materials, the lack of activities and share price. The competitors will speak about Anavex in a negative way and there is nothing to balance that somewhat.
I agree that the data looks promising, but the share price is ridiculously low and that's mostly because they do not know how to build support for the drug. Missling uses his scientific gut feeling to guide him and nobody tells him that it doesn't work this way.
Agree, but is't not at all diverse regarding experience. Again, really nobody has the medical-marketing-sales, market access or launch background. Really nobody!
It's all scientists, regulatory and clin development. Now it's time to go to the next phase, streamline the communications and have good activities with external experts and other stakeholders. There is a lack of focus, external relations and consistency in the story. They are not really aiming to bring the drug to the market ASAP. This is a scientist who doesn't know how to bring something new to the market.
In line with that: the strategic partnership with Partex (a small company nobody knows) with the 'ambition to reshape the future of the biopharma business model' with their 'disruptive ai work', to drive efficiency, effectiveness, and innovation across the value chain with patient-centric focus at every step. All buzzwords! It's ridiculous for a 300M company without a drug on the market. Even BP companies that are 1000x bigger would be more modest. Does he think he is Steve Jobs? Just get a few experienced people on board from big pharma and do your job!
Biochecker, you are right about his background. Also, he does everything himself and seems to think he is brilliant. Maybe he is surrounded with too many slimeballs and nobody provides critical feedback. In the whole company there is nobody with medical-commercial-market access or launch experience. His slide about 'exploring commercial activities' is full of BS as well as claims about having a transformative precision medicine. He needs to bring in people who have launched a drug before, know what to do at this stage, how to present the case and can focus on things that really matter.